An important part of the consistency evaluation of generic drugs is pharmaceutical equivalence research, which includes the useful data of prescription process of generic drugs. Generally speaking, through the research and confirmation of the process parameters of each step of the production unit of the Reference Listed Drugs (RLDs), scientists screen out critical process parameters (CPP) that must be monitored during the preparation process, and obtain the prescription process for the production of generic drugs. The small-scale research for prescription is the main stage of exploring and controlling the range of critical process parameters, with the goal of realizing the scale-up production.In the small-scale research, it is required to fully consider the actual production situation, such as instrument type, adjustable parameter range, environmental control conditions, etc. Based on the product quality attribute parameters and critical process parameters of each process step, Alfa Chemistry provides services of small-scale research for process development of generic drug by adjusting the process parameters related to batch and instrument characteristics to provide the reliable prescription of generic drug.
Application of Small-scale Process Research
- Evaluate and optimize CPP
- Determine the production scale of the formulation
- Provide relevant process parameter ranges for scale-up production of products
Our Services
Identification of critical process steps
Determining the critical process steps of the generic drug is the premise of process development. After the CMA and CPP of the RLDs are identified, the risk assessment of the entire drug production process is carried out to determine the critical process steps that may affect the CQAs of the final product.
Evaluation of critical process steps
Based on rich project experience and professional knowledge, our experts conduct a detailed assessment of each process step, and determine the key factors in each process step that may affect the material properties (such as input CMAs, CPPs, personnel and equipment etc.) and its knowledge space (KS).
Design of experiments (DoEs) analysis
According to the characteristics of each process step, the dissolution characteristics (similarity factor), uniformity, related substances, morphology (appearance/porosity/angle of repose, etc.) are used as response values for these factors, and DoE verification is carried out to preliminarily determine the prescription and process of generic drugs.
1) Factor analysis: such as univariate analysis, partial/fractional factorial design or full factorial design
2) Process optimization: response surface design is used to analyze the reduce the risk
- Study the relationship between CMA, CPP and CQA;
- Establish DS (design space) with the goal of reducing risk;
- Provide the normal operating ranges (NOR);
- Determine the optimal combination of factor levels.
What We Offer for Your Consistency Evaluation
- Detailed production process description
- CMAs, CPPs and CQAs
- Intermediate quality control standards and testing methods
- Process validation information
Our Advantages
- Strong R&D team: Proficient in the drug R&D policies and regulations and they master the R&D process, methodology development, preparation technology development, and document preparation
- State-of-the-art facilities and equipment
- Quality control system: All data is recorded and monitored, and we ensure all tests and inspections are standardized operated and real-time recorded.
